Bio-Medical Waste Management Rules, 1998 & 2016: A Comparative Study

Introduction:

The study here tries to throw a light on the various aspects of the Bio-Medical waste Rules that has changed/amended from Bio-Medical Waste Management Rules, 1998 to Bio Medical Waste Management Rules, 2016. The Amendments/changes that has been done by the Government in the Bio Medical Waste management rules,2016 are for the better disposal of Bio-Medical Waste, through which the society can be a better place to live in.

 

Bio-Medical Waste:

Bio-medical waste is a waste which is generated during diagnosis or treatment of people or animals. This includes all the people and institutes which generate, store, collect, transport, treat, any forms of Bio-Medical Waste. There are many types of Bio-Medical wastes out which some are easy to treat and not harmful or contagious, and the other is very harmful as it can spread highly contagious diseases to the present and the future generation as well. This kind of waste can even be threat to the environment too as it can cause air, water, and soil pollution.

Many studies have stated that health care workers have very less or no knowledge about the disposal of Bio-Medical Waste which can be harmful and may seriously affect the environment. Due to the same reason, there is an increase in the awareness about the Bio-Medical Waste segregation and disposal. In our country there is a very much need of the awareness and knowledge about the same as many reports suggest that there is a lacunae in the practices among the many Health Care Workers. The Bio-Medical Waste Management Rules has been amended several times, but there is a lack of update among Healthcare workers and institutions.

Harmful Effects of Poorly Managed Biomedical Waste:

Biomedical waste when not disposed properly can pose serious risks to society and the environment through air emissions, contamination of water and physical contact.

Improper disposal refers to open dumping, unrestrained burning, and improper handling of waste during generation, collection, storage, transport and treatment.

Improper handling involves unsafe procedures followed during handling of wastes i.e. without wearing protective equipment, poor storage (high temp, high residence), transporting manually for longer distances, uncovered or unpacked containers instead of puncture proof bags, etc. all of which effect hospital workers in different ways.

The following groups are exposed:

Inside Health Care Centers: 

staff- doctors, nurses, auxiliaries, stretcher bearers, patients, scientific and technical personnel, housekeeping staff, laundry, waste managers, maintenance, and lab technicians.

Outside: 

In site and off site transport personnel, waste processing personnel, public, and rag pickers. Improper management of wastewater and sludge can result in contamination of air, soil and water with pathogens and toxic chemicals which may affect all forms of life. Inadequate waste management can cause environmental pollution, unpleasant odors, growth and multiplication of insects, rodents and worms and may lead to transmission of diseases like typhoid, cholera, etc. Infectious agents such as faeces, vomit, saliva, secretions, blood can cause serious health risks on individuals by affecting organs or systems like gastrointestinal, respiratory, eye, skin and cause Anthrax, Meningitis, AIDS, Haemorrhagic Fever, Hepatitis A, B, C, Influenza etc. Research and radio-immunoassay activities may generate small quantities of radioactive gases.

Infections Associated with Different Types of Waste:

Organism	Disease Caused	Related waste
Viruses HIV, Hepatitis B, Hepatitis A, C, Arboviruses, Enteroviruses	AIDS, Infectious Hepatitis, Dengue, Japanese encephalitis, tick-borne, fevers, meningitis, etc.	Infected needles, body fluids, Human excreta, soiled linen, blood
Bacteria Salmonella typhi, vibrio cholera, clostridium Tetani, Pseudomonas, Streptococcus	Typhoid, Cholera, Tetanus, Wound Infections, Septicaemia, Rheumatic fever, endocarditis, skin and soft tissue infections, meningitis, bacteraemia	Human excreta and body fluids in landfills and hospital wards, sharps such as needles, surgical blades in hospital waste
Parasites Wucheraria Bancrofti, Plasmodium	Cutaenous leishmaniosis, Kala Azar, Malaria	Human excreta, blood and body fluids in poorly managed sewage system of hospitals

 

Bio-Medical Waste Management Rules:

Bio-Medical Waste Management Rules were implemented under Environment Protection Act,1986 in our country on 20th July,1998. After that the Rules have undergone many amendments in the passing years. Bio-Medical waste Rules,2016 is the latest Bio-Medical Rules after significant and many changes done to Bio-Medical Rules,1998 keeping in mind the health care of the people. Primarily this waste was divided among various categories. Further multiple categories were clubbed to disposed in four colour coded bags. This was very hard to be remembered by the housekeeping and healthworker staff which formed a very weak section in the Bio Medical Waste Management system. It was found that the Bio-Medical waste generators had their own waste disposal techniques and systems which were not very effective or required significant improvement as they posed a threat to the public as well as the environment.

To undertake all these issues the new Bio-Medical Waste Management Rules were laid down by the ministry of Environment, Forest and Climate change under the Environment Protection Act, 1986 on 28th March, 2016.

Difference between Bio-Medical Waste Management Rules, 1998 and 2016:

The major changes are as follows: (1) the removal of multiple categories and to continue with only four color-codes (2) that no occupier was permitted to establish an on-site treatment and disposal facility if service of a common biomedical waste treatment facility (CBMWTF) is available within a distance of 75 km, and (3) changes in the form numbers of accident reporting, authorization, annual reporting, and appeal. The difference between Bio-Medical Waste Management Rules, 1998 and 2016 has been discussed by dividing it into various points and showing the difference between them.

Duties of the Occupier:

Duties of the occupier are delineated better as it wasn’t delineated in 1998. There is pretreatment by disinfection and sterilization on-site of infectious lab waste blood bags as per the WHO guidelines Occupier ensures liquid waste is segregated at source by pretreatment,  whereas, No pretreatment of waste on-site Chlorinated plastic bags, gloves, and blood bags were recommended. ETP is mandatory Occupier ensures to maintain BMWM register daily and on website monthly Annual report should be made available on the website within two years The occupier (30 bedded) establishes BMWM committee Records of equipment, training, health checkup, and immunization are compulsory whereas any of the above were not mandatory in the Biomedical waste management rules, 1998.

Duties of the CBMWTF:

Duties are delineated better The occupier has to establish barcoding and GPS and ensure occupational safety of all its HCWs by TT and HBV vaccination Reporting of accidents and maintenance of records of equipment, training, and health checkup, whereas, in BMWM Rules, 1998 Duties are not delineated, better Barcoding and GPS not documented and vaccinations for HCWs not documented, Records not documented.

Accident Reporting:

Major accidents are reported to authorities and in annual report whereas, No specific reporting of accidents were mandated in BMWM Rules,1998.

Deep Burial:

As per rules 2016, Deep Burial is an option for only remote and rural areas and not in towns and villages with less than 5 lakhs population.

Chemical Treatment:

Changes to chemical treatment from 1% hypochlorite to 10% hypochlorite in 2016 which was again rolled back to 1%-2% in 2018.

Fetes:

No demarcation of foetus was mentioned in BMWM rules 1998 but the new amendment of rules in 2016 said Foetus younger than the age of viability is to be treated as human anatomical waste.

Drugs:

Antibiotics and other drugs and solid chemical waste suggested for incineration Cytotoxic drugs: return back to supplier and incineration up to 1200 C whereas, the rules, 1998 mentioned that all the drugs to be discarded in the black bag for cytotoxic drugs, destruction and drugs disposal in secured landfills

Liquid-infected waste:

Effluent treatment plant is mandatory, and effluent to conform to standards mentioned whereas rules, 1998 states chemical treatment and discharge into drains to conform to effluent standards mentioned.

Microbiology and biotechnology waste:

Rules, 2016 states the Pre-treatment of infectious waste as per the WHO guidelines whereas pre-treatment was not at all mandatory in rules, 1998.

Infected plastics, sharps and glass:

The infected plastics and sharps go in the red bag and the white container, respectively, and are sent to authorized recyclers. The glass articles are discarded in a cardboard box with blue marking whereas, infected plastics, metal sharps, and glass go in the blue container with disinfectant, and local autoclaving/microwaving/incineration is recommended.

Recycling:

A focus on recycling of plastic, sharps, and glass to authorized recyclers whereas, no such mention in rules, 1998.

Form I:

Changed to accident reporting from application for authorization.

Form-II:

Changed to Authorization or renewal of Authorization from Annual Report in rules, 1998.

Form-III:

Changed to Authorization for opening a facility for collectin, reception, treatment, storage, transport, and disposal of BMW from Accident Reporting in BMW Rules in 1998.

Form-IV:

Changed to Annual Report from Authorization for operating a facility for collection, reception, treatment, storage, transport, and disposal of BMW.

Form-V:

Changed to Application for filing appeal against order passed by the prescribed authority from Application for filing appeal against order passed by the prescribed authority in rules 1998.

FURTHER DEVELOPMENTS

Further, after publishing Bio-Medical Waste Management Rules, 2016 the Ministry of Environment, Forest and Climate change made some amendments and published Biomedical Waste Management (Amendment) Rules, 2018 on 16th March, 2018. In this amendment, typographical errors were corrected, rules regarding non-infectious wastes were updated.

 

Author: Arjun Rathod

Editor: Adv. Aditya Bhatt & Adv. Chandni Joshi